NCT07228819

Brief Summary

This project compares four SAGE implementation strategies to evaluate effectiveness in implementation, sustainability, cost, and child health outcomes. Using the CFIR and MOST frameworks, the investigators will analyze key components to identify the most efficient and scalable strategies. Data will come from ECE site audits, surveys, social network analysis, and child health assessments. Findings will inform sustainable, cost-effective approaches to improve early childhood nutrition and physical activity.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
871

participants targeted

Target at P75+ for not_applicable

Timeline
45mo left

Started Oct 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress14%
Oct 2025Dec 2029

Study Start

First participant enrolled

October 2, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 14, 2025

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2029

Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

4.2 years

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

ChildPreschoolNutritionExerciseHealthPolicySchoolGarden

Outcome Measures

Primary Outcomes (1)

  • Implementation

    Proportion of teachers who rate SAGE as acceptable, appropriate, and feasible to implement. Proportion of teachers completing at least 70% of curriculum activities as measured by weekly fidelity checklists.

    Baseline, 6 mos post-test, 16 months follow up

Secondary Outcomes (4)

  • Locomotor skills

    Baseline, 6 mos post-test, 16 months follow up

  • Veggiemeter

    Baseline, 6 mos post-test, 16 months follow up

  • Eating in the absence of hunger

    Baseline, 6 mos post-test, 16 mos follow up

  • Moderate to vigorous physical activity

    Baseline, 6 mos post-test, 16 mos follow up

Study Arms (8)

Experimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative

EXPERIMENTAL

Schools will receive all three strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video

Behavioral: SAGE BasicBehavioral: SAGE e-supportBehavioral: SAGE in-person supportBehavioral: Learning collaborative

(S1) E-support, (S2) in-person support

EXPERIMENTAL

Schools will receive all two of the three strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules.

Behavioral: SAGE BasicBehavioral: SAGE e-supportBehavioral: SAGE in-person support

(S3) Learning collaborative, (S2) in-person support

EXPERIMENTAL

Schools will receive two strategies: (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video

Behavioral: SAGE BasicBehavioral: SAGE in-person supportBehavioral: Learning collaborative

(S2) in-person support

EXPERIMENTAL

Schools will receive all one strategy: (S2) in person staff support and teacher training which requires SAGE curriculum activities to be completed in a single session to accommodate research staff schedules.

Behavioral: SAGE BasicBehavioral: SAGE in-person support

Control

EXPERIMENTAL

Schools will receive SAGE baseline curriculum access and study materials.

Behavioral: SAGE Basic

(S1) E-support, (S3) Learning collaborative

EXPERIMENTAL

Schools will receive all two strategies: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includs semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline. (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video

Behavioral: SAGE BasicBehavioral: SAGE e-supportBehavioral: Learning collaborative

(S1) E-support

EXPERIMENTAL

Schools will receive all one strategy: (S1) e-support implementation package which comprises the SAGE basic with the additional e-support implementation package that includes semi-weekly teacher text messages, a weekly check in phone call, and a teacher hotline.

Behavioral: SAGE BasicBehavioral: SAGE e-support

(S3) Learning collaborative

EXPERIMENTAL

Schools will receive one strategy: (S3) virtual learning collaborative which will be developed in consultation with an advisory board with the goal of increasing the social network connectivity and community capacity about garden-based outdoor learning in preschoolers. ECE sites assigned to this condition will receive access to the original SAGE basic plus an online portal (such as a moderated Facebook private group) where they will be able to share information and interactions about garden learning. Monthly implementation "tips and tricks" video

Behavioral: SAGE BasicBehavioral: Learning collaborative

Interventions

SAGE BasicBEHAVIORAL

SAGE basic includes installation/refresh of an ECE garden, 12 lesson curriculum with delivery materials.

(S1) E-support(S1) E-support, (S2) in-person support(S1) E-support, (S3) Learning collaborative(S2) in-person support(S3) Learning collaborative(S3) Learning collaborative, (S2) in-person supportControlExperimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative
SAGE e-supportBEHAVIORAL

Semi-weekly teacher text messages, a monthly newsletter and a teacher hotline

(S1) E-support(S1) E-support, (S2) in-person support(S1) E-support, (S3) Learning collaborativeExperimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative

Weekly in person support and training following the "see one, do one, teach one" model

(S1) E-support, (S2) in-person support(S2) in-person support(S3) Learning collaborative, (S2) in-person supportExperimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative

Access to an online information-sharing portal, monthly newsletter, annual face-to-face half day conference

(S1) E-support, (S3) Learning collaborative(S3) Learning collaborative(S3) Learning collaborative, (S2) in-person supportExperimental: (S1) E-support, (S2) in-person support, (S3) Learning collaborative

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Allergy or condition which prohibits participation in garden-based curricula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 14, 2025

Study Start

October 2, 2025

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Data collected as part of this project will be de-identified and made available on public websites that may be shared with investigators working under an institution with a Federal Wide Assurance (FWA). As there is no specific data sharing repository for the funding agency, the investigators will identify possible other repositories that may be appropriate to use. For whatever NIH-funded repository is advised to be used, the investigators acknowledge that this repository will have policies and procedures in place that will provide data access to qualified researchers, consistent with NIH data sharing policies and applicable laws and regulations. Data will be deposited to the repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Study protocol and statistical Analysis Plan will be available by January 2028 with no end date.
Access Criteria
Data could be used for secondary study purposes such as finding additional relationships related to implementation and sustainability of garden based education in early care and education. Data will be openly available.

Locations